MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients

October 23, 2016 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brain Angiogenesis Induced by Hyperbaric Oxygen Therapy Can be Visualized by Perfusion MRI in Brain Injury Patients

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment.

The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Retrospective analysis of patients suffering from chronic neuro-cognitive damage due to TBI treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel

Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients are treated with 50-70 daily hyperbaric sessions, 5 days per week. Each session consists of 60 minutes exposure to 100% oxygen at 1.5 ATA.

All patients that underwent MRI before and after HBOT. The MRI protocol included DSC, DCE, DTI, FLAIR, T2 and SWI.

MRI scans sequences parameters:

* DSC: 50 T2*-weighted gradient-echo echo planar imaging (EPI) volumes were acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA. Sequence parameters: TR=2,300 ms, TE= 40ms, flip angle = 30°, voxel size = 1.8 x1.8, Matrix = 128x128, No. of slices = 25, Slice thickness = 3.9 mm.

  • DCE: three T1 weighted Fast Low Angle SHot (FLASH) volumes were acquired with different flip angles (2, 7 and 15 degrees) followed by 70 dynamic T1 weighted FLASH volumes with flip angle of 15 degrees after bolus injection of Gd-DTPA. Sequence parameters: before injection: TR=4.09, after injection - TR=4.86 ms, TE= 1.76 ms, Voxel size = 1.5x1.5, Matrix = 192X192, No. of slices = 26, Slice thickness = 3.5mm.
  • DTI: 30 diffusion weighted images were scanned with different gradient directions (b=1000) and one volume without diffusion weighting, with the following parameters: TR=10,300 ms, TE=89 ms, Voxel size = 1.8X1.8, Matrix = 128 X 128, No. of slices = 63, Slice thickness = 2.2mm

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf-Harofeh Medical Center
      • Zerifin,, Israel, 70300
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective analysis of patients suffering from chronic neuro-cognitive damage treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel from September 2013 .

Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). Treatment was approved by the institutional review board of the hospital.

Description

Inclusion Criteria:

  • Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).

Exclusion Criteria:

  • did no complete treatment or did not complete examinations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brain trauma
Patients with chronic brain injury that have been treated with Hyperbaric oxygen therapy and underwent MRI imaging and cognitive tests before and after the treatment
Other: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perfusion MRI changes
Time Frame: Before and after treatment. Treatment is approximately 3 months.
Before and after treatment. Treatment is approximately 3 months.
Microstructure changes (DTI)
Time Frame: Before and after treatment. Treatment is approximately 3 months.
Before and after treatment. Treatment is approximately 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0030-15-ASF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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